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White Paper: Hypertension

blood pressure cuffs and meters, heart monitors. IDEAL LIFE BODY MANAGER, IDEAL LIFE BP MANAGER, IDEAL

LIFE GLUCO MANAGER, IDEAL LIFE POD, REALIZING THE VISION OF A BETTER TOMORROW, Leveraging the

Power of Communication, Real time health and wellness information on demand, wireless remote health and wellness

management, and Solutions for better healthcare through advanced communication technology are all proprietary

trademarks of IDEAL LIFE INC. Contents are covered by one issued U.S. patent and one or more U.S. patents pending.

The information disclosed in this document is confidential and proprietary information of IDEAL LIFE INC. The information

is being provided on the assumption that it will be treated confidentially and for the sole purpose of informing clinical

professionals of suggested care practices present in public literature. The information should not be used as care practice

guidelines and health care professionals should use their own professional judgment when treating patients.

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Hypertension

Growing Problem -73 million Americans have high blood pressure (defined as an

individual: with systolic pressure of 140 mmHg or greater and/or diastolic pressure of 90

mmHg or greater, taking antihypertensive medication, or being told at least twice as

having high blood pressure by a physician or other healthcare professional). Nearly one

in three U.S. adults has hypertension. About 69% of people who have a first heart attack,

77% who have a first stroke, and 74% with heart failure have blood pressure higher than

140/90 mmHg¹.

Consequence - Among those individuals with hypertension age 18 and older, 71.8% are

aware of their condition, and 61.4% are currently undergoing treatment. However, just

35.1% have their blood pressure under control while 64.9% do not. This large gap

continues despite the facts that more than 90% of adults with hypertension have health

insurance, and hypertension is the leading cause of visits to the doctor. If blood pressure

control could be improved, cardiovascular morbidity and mortality would decrease

significantly².

Cost - The estimated direct and indirect cost of high blood pressure for 2008 is $69.4

billion. This is probably an underestimation because of the costs of coronary heart

disease ($156.4 billion), Stroke ($65.5 billion) and heart failure ($34.8 billion) all having

a high association with hypertension³. Approximately 12.8% of all deaths (7.1 million)

and 4.4% of all disability life-years lost (64.3 million) in the year 2000 were due to

cardiovascular disease (CVD) attributable to uncontrolled Blood Pressure (BP).

Opportunity - Controlled blood pressure has been associated with a 35-40% mean

reduction in stroke incidence, 20-25% mean reduction in myocardial infarctions and more

than 50% reduction in heart failure. An increase in 20 mmHg systolic or 10 mmHg

diastolic blood pressures doubles the risk of cardiovascular disease. A 12 mmHg

decrease in stage 1 hypertensive patients with cardiovascular risk factors will prevent 1

death in every 11 treated patients over 10 years and in patients with cardiovascular

disease and /or target organ damage 1 death in every 9 patients will be prevented⁴.

The use of home blood pressure monitoring is recommended by several national and

international guidelines for the management of hypertension, including The American

Heart Association, The American Society of Hypertension, The Canadian Hypertension

Society, The European Society of Hypertension, The British Hypertension Society, The

European Society of Hypertension, The Japanese Hypertension Society, the World Health

Organization-International Society of Hypertension, and JNC 7 which is the generally

accepted guideline for the United States⁵.

The IDEAL LIFE Solution™ - The IDEAL LIFE Hypertension program has been

successfully tested to optimize at-home treatment. Through the use of a wireless enabled

blood pressure device, combined with the remote IDEAL LIFE information management

platform™ a patient’s blood pressure and heart rate are immediately communicated

remotely to the hypertension automatic data analysis engine. Within seconds of taking a

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blood pressure and heart rate measurement, information is logged and analyzed, and

when appropriate, alerts generated and communicated. This allows for timely adjustment

of treatment and proper management of the chronic condition.

IDEAL LIFE Results - In an analysis of 904 patients using real-time readings on the

hypertension management program for a period of six months, the average reduction of

systolic blood pressure was 9 mmHg, from 147 mmHg to 138 mmHg. The largest

reduction seen on any one patient was 77 mmHg, from 221 to 144. 48% of the patients

had a greater than 10 mmHg reduction in their average systolic blood pressure (SBP).

61% of the patients had a greater than 5 mm Hg in their SBP.

Before entering the program, 42% of patients had an average systolic blood pressure of

≥150 mmHg. These patients experienced an average reduction of 19 mmHg, from an

average of 162 mmHg to an average of 143 mmHg. 21% of patients had an average

systolic blood pressure of ≥160 mmHg. These patients experienced an average reduction

of 26 mmHg, from an average of 171 mmHg to an average of 145 mmHg. 42% of

patients experienced a ≥12 mmHg drop in their average systolic blood pressure, from an

average of 158 mmHg to an average of 134 mmHg.

IDEAL LIFE Hypertension program after six months of 904

patients

180

170

160

Baseline SBP

150

6 months SBP

140

130

120

110

100

Total

Patients

population ≥150 mmHg≥160 mmHg ≥12 mmHg

drop

These decreases in blood pressure are very significant because controlled blood pressure

has been associated with a 35-40% mean reduction in stroke incidence, 20-25% mean

reduction in myocardial infarctions and more than 50% reduction in heart failure. A 12

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mmHg drop in average systolic blood pressure will save one life in every 11 treated

patients over ten years⁶, in the 904 patient population almost 40 lives would be saved.

The IDEAL LIFE solution™ has displayed through remote monitoring and timely

interventions the opportunity to save lives and decrease serious complications which will

allow patients to live longer and healthier lives.

The phenomenon of reporting bias is another important aspect that the IDEAL LIFE

System overcomes. Home BP monitoring has shown to be a better predictor of morbidity

than office BP readings, although traditionally, home readings have the problem of

reporting bias. The phenomenon of reporting bias occurs when patients do not accurately

report their BP readings. A possible explanation for the reporting bias is some patients

lower their BP readings to avoid additional antihypertensive medication and some report

higher readings to emphasize the severity of their hypertension⁷. IDEAL LIFE avoids

this bias, among others, by automatically communicating the data when a measurement

reading is taken, remotely updating the patient’s record independently of the patient.

Another issue of concern includes possible misdiagnoses when using unreliable office

readings as the sole tool of assessment. Known as the white coat effect, patients in the

community can experience a high office blood pressure in the physician office with

normal home blood pressure. A substantial proportion of patients receiving

antihypertensive medication are being over treated due to this phenomenon⁸. The IDEAL

LIFE System allows the treating clinician to receive the home blood pressure information

in a easy fashion to overcome potential concerns of misdiagnoses related to unreliable

office readings.

The case studies below illustrate a few examples of the above noted issues concerning

current usual care practices. An example of the white coat effect is an 80 year old man

with office systolic blood pressure readings above 150 mmHg and 160 mmHg. His PCP

doubled the patient’s dose of nifedipine. The patient continued monitoring on the IDEAL

LIFE system and BP readings below 100/60 mmHg were discovered. The patient was

experiencing hypotensive symptoms as well. The patient’s dose was lowered and his

hypertension was brought under control.

Another case study demonstrating the concern of using unreliable office readings as the

sole tool of assessment relates to masked hypertension or reverse white coat effect, and

was observed in a female patient on the IDEAL LIFE system at 79 years of age. She had

a history of multiple mini strokes yet was reported to have consistently normal office

blood pressure readings. After initiating home blood pressure monitoring on IDEAL

LIFE it was identified that her home blood pressure readings ranged from 180/100

mmHg to 220/140 mmHg. The patient was instantly identified as hypertensive and a

change in drug therapy was initiated which subsequently allowed the patient to achieve

goal BP.

A case study of a 90 year old female patient, demonstrated the possible adjustments that

can be undertaken to prevent an adverse event and a possible hospitalization. The patient

was on antibiotics for a GI infection, had complaints of diarrhea, excessive urination,

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severe dizziness, and weakness. The blood pressure trend showed a decline on the

IDEAL LIFE system, in response the patient was contacted. It was discovered the patient

was still taking a diuretic that she had previously been told to discontinue. The patient’s

medications were adjusted and a hypotensive event and possible dehydration were

reversed and prevented.

Hypertension is a risk factor for heart disease, kidney disease and stroke. Patients

achieving target blood pressure can prevent many of these devastating and costly

diseases. It has been shown through the proper use of medication these complications

can be prevented⁹. Using reliable at home health information can assist patients achieve

long term management of their chronic conditions. IDEAL LIFE is a proven solution

that delivers home health information through a cost effective and easy to use platform,

that helps modify treatment to achieve reductions in morbidity and mortality.

American Heart Association. Heart Disease and Stroke Statistics — 2008 Update. Dallas, Texas:

B.B. Green et al. Electronic Communications and Home Blood Pressure Monitoring

(e-BP) study: Design, delivery, and evaluation framework, Contemporary Clinical Trials 29

(2008) 376-395

American Heart Association. Heart Disease and Stroke Statistics — 2008 Update. Dallas, Texas:

A. W. Chobanian et al. The seventh report of the joint national committee on prevention,

detection, evaluation, and treatment of High Blood pressure. JAMA, May 21, 2003, Vol. 289, No. 19

Pickering et al AHA/ASH/PCNA Call to Action on Home BP Monitoring Hypertension published

online May 22, 2008

A. W. Chobanian et al. The seventh report of the joint national committee on prevention,

detection, evaluation, and treatment of High Blood pressure. JAMA, May 21, 2003, Vol. 289, No. 19

M.G. Myers. Reporting bias in self-monitoring of blood pressure. Blood Pressure Monitoring.

2001, 6:181-183

M.G. Myers et. al. Overtreatment of Hypertension in the Community? American Journal of

Hypertension. May 1996, 9:419-425

F.H.H. Leenan et. al. Results of the Ontario Survey on the Prevalence and Control of

Hypertension. Canadian Medical Association Journal. May 2008, 178 (11)